CDER, CDRH Currently Writing Theranostics Draft Guidance for Jointly Marketed Products | GenomeWeb

The head of the FDA’s Center for Drug Evaluation and Research and the director of the agency’s Office of In Vitro Diagnostics are currently co-writing a new draft guidance on the use of jointly marketed diagnostic-therapeutic products, SNPtech Pharmacogenomics Reporter has learned.

The news, which comes following the release of two related draft guidance documents, is aimed at meeting head-on the rise of so-called theranostics products. Microarrays are widely expected to play a pivotal role in the development of such products.

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